Lidocaine for Headache

(LIGHT 2 Trial)

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether injecting lidocaine, a local anesthetic, into specific brain blood vessels can relieve chronic migraines. Participants will receive either the lidocaine treatment or a placebo (a harmless saline solution) for comparison. Ideal candidates are adults referred for a specific brain imaging procedure who struggle with severe, hard-to-treat migraines. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in migraine treatment.

Is there any evidence suggesting that lidocaine is likely to be safe for humans?

Studies have shown that lidocaine is generally well-tolerated when used in specific ways. Research indicates that lidocaine is safe, with no serious side effects reported. This suggests that lidocaine injections, like those in this trial, might also be safe. However, excessive use of lidocaine can be harmful, especially in young children, making it crucial to follow recommended doses. While lidocaine is already used in some treatments, its use in this trial is still being tested for safety and effectiveness.12345

Why do researchers think this study treatment might be promising for headaches?

Lidocaine is unique because it targets headaches through a new delivery method: intra-arterial administration. Unlike typical treatments for headaches, like oral pain relievers or triptans, lidocaine is directly administered into the bloodstream, which may lead to faster and more targeted pain relief. Researchers are excited about this approach because it could offer a rapid solution for those suffering from severe headaches, potentially reducing the time it takes to feel relief compared to standard options.

What evidence suggests that lidocaine might be an effective treatment for chronic headaches?

Research has shown that lidocaine, a common pain reliever, can help reduce migraine pain. Almost 88% of people with chronic migraines experienced less pain after receiving lidocaine through an IV. In smaller studies, injecting lidocaine directly into brain arteries relieved headaches for some individuals. This trial will compare intra-arterial lidocaine, which participants may receive, with a sham comparator using intra-arterial saline. These findings suggest that lidocaine could effectively treat chronic headaches.23678

Who Is on the Research Team?

MK

Manisha Koneru, MD

Principal Investigator

The Cooper Health System

Are You a Good Fit for This Trial?

This trial is for individuals suffering from chronic headaches, including migraines and vestibular migraines. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors that could interfere with the study or their safety.

Inclusion Criteria

Referred for diagnostic angiography
I am 18 years old or older.
I have been diagnosed with severe, untreatable migraines.
See 1 more

Exclusion Criteria

Baseline HIT-6 score less than 60 (severe)
Pregnant, breastfeeding, or unwilling to practice contraception during participation in the study
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intra-arterial lidocaine or saline for headache treatment

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Lidocaine

Trial Overview

The study is testing if injecting lidocaine directly into two brain blood vessels can relieve intractable headaches. Participants will receive either lidocaine or a saline solution to compare effectiveness.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 Intervention
Group II: ShamPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Daniel A Tonetti, MD

Lead Sponsor

Citations

Intranasal lidocaine for acute migraine: A meta-analysis ... - PMC

Intranasal lidocaine has been shown to be effective in treating patients with acute migraines; however, its efficacy is still controversial.

Chronic migraine: Common anesthetic could provide relief

Nearly 88% of chronic migraine patients receiving intravenous lidocaine during hospitalization showed a reduction in pain intensity at discharge ...

Middle meningeal artery lidocaine infusion for refractory ...

Two small case series (six patients in total) have reported successful headache relief with direct intra-arterial lidocaine infusions into the middle meningeal ...

Bilateral Middle Meningeal Artery Lidocaine Infusion for ...

To observe a ≥50% reduction in monthly migraine headache days in one month post intra-arterial lidocaine infusion into the bilateral middle meningeal artery.

A single infusion of intravenous lidocaine for primary ...

The main efficacy outcome was change in headache/facial pain intensity using a verbal rating scale (VRS) 0–10. Patients were considered ...

A Phase 1 Clinical Trial for Safety

The data from this phase 1 clinical trial suggest favorable safety and tolerability of the investigational intervention. No serious adverse ...

Intranasal Lidocaine for Treatment of Migraine

Intranasal lidocaine can be absorbed systemically and could be potentially toxic if the patient uses the agent excessively. The risk for toxicity due to ...

Lidocaine (injection route) - Side effects & uses

Because of this medicine's toxicity, it should be used with extreme caution in children younger than 6 months of age. Recommended doses should not be exceeded, ...